A cluster-randomized controlled trial of a computerized antithrombotic risk assessment tool to optimize stroke prevention in general practice: a study protocol

BACKGROUND: Therapy for stroke prevention in older persons with atrial fibrillation (AF) is underutilized despite evidence to support its effectiveness. To prevent stroke in this high-risk population, antithrombotic treatment is necessary. Given the challenges and inherent risks of antithrombotic therapy, decision-making is particularly complex for clinicians, necessitating comprehensive risk:benefit assessments. Targeted interventions are urgently needed to support clinicians in this context; the Computerized Antithrombotic Risk Assessment Tool (CARAT) offers a unique approach to this clinical problem. METHODS/DESIGN: This study (a prospective, cluster-randomized controlled clinical trial) will be conducted across selected regions in the state of New South Wales, Australia. Fifty GPs will be randomized to either the ‘intervention’ or ‘control’ arm, with each GP recruiting 10 patients (aged ≥65 with AF); target sample size is 500 patients. GPs in the intervention arm will use CARAT during routine patient consultations to: assess risk factors for stroke, bleeding and medication misadventure; quantify the risk/benefit ratio of antithrombotic treatment, identify the recommended therapy, and decide on the treatment course, for an individual patient. CARAT will be applied by the GP at baseline and repeated at 12 months to identify any changes to treatment requirements. At baseline, the participant (patients and GPs) characteristics will be recorded, as well as relevant practice and clinical parameters. Patient follow up will occur at 1, 6, and 12 months via telephone interview to identify changes to therapy, medication side effects, or clinical events. DISCUSSION: This project tests the utility of a novel decision support tool (CARAT) in improving the use of preventative therapy to reduce the significant burden of stroke. Importantly, it targets the interface of patient care (general practice), addresses the at-risk population, evaluates clinical outcomes, and offers a tool that may be sustainable via integration into prescribing software and primary care services. GP support and guidance in identifying at risk patients for the appropriate selection of therapy is widely acknowledged. This trial will evaluate the impact of CARAT on the prescription of antithrombotic therapy, its longer-term impact on clinical outcomes including stroke and bleeding, and clinicians perceived utility of CARAT in practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12613000060741.